MAUDE Adverse Event Report: ROI CPS, LLC REGARD; CABG A & B

Model Number	CV00361P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Tears were discovered in the vented bags and sometimes through to the back table cover.No harm to patient and no delay to case.

• Brand Name: REGARD
• Common Device Name: CABG A & B
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• MDR Report Key: 12159499
• Report Number: 3014527682-2021-00013
• Device Sequence Number: 11671371
• Product Code: OEZ
• UDI-Device Identifier: 10194717107255
• UDI-Public: 10194717107255
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CV00361P
• Device Catalogue Number: 800208016
• Device Lot Number: 88054P, 87219P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1